Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055887
Status:
WITHDRAWN
Last Update Posted:
2013-05-10
First Post:
2003-03-06
Brief Title:
Chemotherapy and Radiation Therapy With or Without Efaproxiral in Treating Patients With Stage III Non-Small Cell Lung Cancer
Sponsor:
Spectrum Pharmaceuticals Inc
Organization:
Spectrum Pharmaceuticals Inc
Study Overview
Official Title:
A Phase III Randomized Open-Label Comparative Study of Induction Chemotherapy Followed by Thoracic Radiation Therapy With Supplemental Oxygen With or Without Concurrent RSR13 Efaproxiral in Patients With Locally Advanced Unresectable Stage IIIAIIIB Non-Small Cell Lung Cancer
Status:
WITHDRAWN
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study never started No patients were enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Drugs such as efaproxiral may make the tumor cells more sensitive to radiation therapy It is not yet known if chemotherapy combined with radiation therapy is more effective with or without efaproxiral in treating non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of chemotherapy combined with radiation therapy with or without efaproxiral in treating patients who have stage III non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of chemotherapy combined with radiation therapy with or without efaproxiral in treating patients who have stage III non-small cell lung cancer
Detailed Description:
OBJECTIVES
Compare the overall survival of patients with stage IIIA or IIIB non-small cell lung cancer treated with induction chemotherapy followed by radiotherapy with or without efaproxiral
Compare time to progression response rate and pattern of failure of patients treated with these regimens
Determine the safety of efaproxiral in these patients
Determine the pharmacokinetics of efaproxiral in these patients
Compare quality of life of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to chemotherapy regimen Karnofsky performance status 70-80 vs 90-100 and disease stage IIIA vs IIIB
Induction therapy phase Patients receive 1 of the following induction chemotherapy regimens
Paclitaxel and carboplatin Patients receive paclitaxel IV and carboplatin IV on day 1 Treatment repeats every 21 days for a total of 2 courses
Cisplatin and gemcitabine Patients receive cisplatin IV on day 2 and gemcitabine IV on days 1 8 and 15 Treatment repeats every 28 days for a total of 2 courses
Cisplatin and vinorelbine Patients receive cisplatin IV on day 1 and vinorelbine IV on days 1 8 and either 15 or 22 Treatment repeats every 28 days for a total of 2 courses
Randomized phase Within 42 days after completion of chemotherapy patients are randomized to 1 of 2 treatment arms
Arm I Patients receive efaproxiral IV over 30-45 minutes with supplemental oxygen and then undergo concurrent radiotherapy 5 days a week for 7 weeks
Arm II Patients receive supplemental oxygen and undergo radiotherapy as in arm I
Quality of life is assessed at baseline on days 1 and 16 of radiotherapy monthly for 3 months every 3 months for 2 years every 6 months for 3 years and then annually thereafter
Patients are followed monthly for 3 months every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 659 patients will be accrued for this study
Compare the overall survival of patients with stage IIIA or IIIB non-small cell lung cancer treated with induction chemotherapy followed by radiotherapy with or without efaproxiral
Compare time to progression response rate and pattern of failure of patients treated with these regimens
Determine the safety of efaproxiral in these patients
Determine the pharmacokinetics of efaproxiral in these patients
Compare quality of life of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to chemotherapy regimen Karnofsky performance status 70-80 vs 90-100 and disease stage IIIA vs IIIB
Induction therapy phase Patients receive 1 of the following induction chemotherapy regimens
Paclitaxel and carboplatin Patients receive paclitaxel IV and carboplatin IV on day 1 Treatment repeats every 21 days for a total of 2 courses
Cisplatin and gemcitabine Patients receive cisplatin IV on day 2 and gemcitabine IV on days 1 8 and 15 Treatment repeats every 28 days for a total of 2 courses
Cisplatin and vinorelbine Patients receive cisplatin IV on day 1 and vinorelbine IV on days 1 8 and either 15 or 22 Treatment repeats every 28 days for a total of 2 courses
Randomized phase Within 42 days after completion of chemotherapy patients are randomized to 1 of 2 treatment arms
Arm I Patients receive efaproxiral IV over 30-45 minutes with supplemental oxygen and then undergo concurrent radiotherapy 5 days a week for 7 weeks
Arm II Patients receive supplemental oxygen and undergo radiotherapy as in arm I
Quality of life is assessed at baseline on days 1 and 16 of radiotherapy monthly for 3 months every 3 months for 2 years every 6 months for 3 years and then annually thereafter
Patients are followed monthly for 3 months every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 659 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ALLOS-RSR13RT-013ELITE | None | None | None |